Iras Perimeter
FDA 510(k) K864012 · Randwal Instrument Co., Inc.
510(k) numberK864012
Submission
- Device name
- Iras Perimeter
- Applicant
- Randwal Instrument Co., Inc.
Southbridge, MA, US - Received
- October 15, 1986
- Decision date
- December 12, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HPJ – Instrument, Visual Field, Laser
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1360
- Specialty
- Ophthalmic
Other 510(k)s with product code HPJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K853556 | Laser IrasHPJ · Traditional | Randwal Instrument Co., Inc. | 11/01/1985SE |
| K822415 | The Ocuplot DHPJ · Traditional | Coherent Medical Division | 09/07/1982SE |
| K813429 | Laser Photocoagulator Argon Med. LaserHPJ · Traditional | American Laser Corp. | 01/22/1982SE |
| K781507 | RetinometerHPJ · Traditional | Coburn Optical Ind., Inc. | 11/15/1978SE |
More from Coburn Optical Ind., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873990 | Iras Eds Interferometric StimulatorHLX · Traditional | 02/05/1988SE |
| K873987 | Iras Glare TesterHLJ · Traditional | 11/24/1987SE |
| K853556 | Laser IrasHPJ · Traditional | 11/01/1985SE |
| K842567 | Portable AcuiometerHLJ · Traditional | 08/15/1984SE |
| K827577 | Variable Contrast Acuiometer, Diagnostic Laser Interferometer · Traditional | 01/24/1983SE |
Questions and answers
When was Iras Perimeter cleared by the FDA?
Iras Perimeter (K864012) received a 510(k) decision of Substantially Equivalent on December 12, 1986, 58 days after the submission was received.
What is the product code of K864012?
The FDA product code is HPJ – Instrument, Visual Field, Laser, a Class II (moderate risk) device regulated under 21 CFR 886.1360.